NCT01355055

Brief Summary

Primary hypothesis: Catheter-based renal denervation reduces central sympathetic activation in patients with refractory hypertension. Secondary hypotheses:

  1. 1.The magnitude of the individual depressor response after catheter-based renal denervation depends on the extent of sympathoinhibition.
  2. 2.Both, the reduction in arterial pressure and in central sympathetic activation are sustained over time up to 24±3 months after catheter-based renal denervation.
  3. 3.Catheter-based renal denervation resets the sympathetic baroreflex to lower blood pressure values.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

May 17, 2011

Status Verified

March 1, 2011

First QC Date

May 16, 2011

Last Update Submit

May 16, 2011

Conditions

Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with refractory hypertension, in whom catheter-based renal denervation is indicated and who are scheduled for this procedure, will be recruited from the outpatient clinic.

You may qualify if:

  • Refractory hypertension (as defined by the WHO: poorly controlled hypertension (\>140/90 mmHg) despite adequate doses of at least three antihypertensive drugs including a diuretic)
  • Men or women aged \>18 years
  • Intact peroneal nerve
  • Written informed consent

You may not qualify if:

  • Diseases, dysfunctions, or medications (such as NET inhibitors) that exclude a participation in the study according to the investigator.
  • Legal incompetence or circumstances that interfere with the patient´s ability to fully understand scope, relevance, and/or consequences of participation in this study.
  • People in custody
  • hypersensitivity to clonidine, phenylephrine, or nitroprusside-sodium
  • sick sinus syndrome, second or third degree AV block, bradycardia \< 50 bpm (contraindication for clonidine)
  • endogenous depression (contraindication for clonidine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Germany

RECRUITING

Related Publications (1)

  • Brinkmann J, Heusser K, Schmidt BM, Menne J, Klein G, Bauersachs J, Haller H, Sweep FC, Diedrich A, Jordan J, Tank J. Catheter-based renal nerve ablation and centrally generated sympathetic activity in difficult-to-control hypertensive patients: prospective case series. Hypertension. 2012 Dec;60(6):1485-90. doi: 10.1161/HYPERTENSIONAHA.112.201186. Epub 2012 Oct 8.

    PMID: 23045466DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Heusser Karsten, MD

CONTACT

+495115322723heusser.karsten@mh-hannover.de

Reuter Julia, MD

CONTACT

+495115322827reuter.julia@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

March 1, 2011

Last Updated

May 17, 2011

Record last verified: 2011-03

Locations

DE(1)